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Quality Assurance Systems Analyst
2 months ago
RxSight Inc. is a pioneering company in ophthalmic medical technology, renowned for its innovative adjustable intraocular lens (IOL) designed for post-cataract surgery customization. Our mission is to transform the premium cataract surgery experience, empowering surgeons to collaborate with patients for optimal results tailored to each unique vision.
Key Responsibilities- Acquire an in-depth understanding of our product offerings and collaborate with diverse teams to maintain operational effectiveness.
- Oversee the management, monitoring, and enhancement of the non-conformance system to align with both internal and external standards.
- Support the upkeep of quality management systems, including Corrective Actions, Document Control, and Employee Training.
- Engage in innovative problem-solving to refine and optimize processes as the organization evolves.
- Compile and present quality performance metrics to educate stakeholders on system health and effectiveness.
- Assist in both internal and external compliance audits.
- Ensure adherence to quality regulations, including tracking updates in regulatory standards and managing external compliance requirements.
Essential Skills and Experience:
- Familiarity with quality management systems and medical device regulatory compliance is preferred.
- Understanding of ISO 13485, 11979, 14971, and 21 CFR 820/Part 11 standards.
- Proficient in Microsoft Office Suite, including Word, Excel, Smartsheet, and PowerBI.
- A detail-oriented individual with a curious mindset and a passion for problem-solving.
- Excellent communication and teamwork abilities, capable of collaborating across various departments.
- Adept at training individuals with diverse backgrounds and learning preferences, demonstrating flexibility in adapting to daily changes.
- A minimum of a Bachelor's Degree with at least 2 years of relevant professional experience.
- Proficiency in Microsoft Office tools is required.
- Experience with QAD is a plus.
- Must be a U.S. citizen or Permanent Resident.
- Strong decision-making, organizational, and collaborative skills are essential.
- Completion of training as outlined in the position's training plan is mandatory.
- Annual completion of training on specific compliance policies is required.
- ASQ certification or CQE is recommended but not mandatory.
- Proficient in utilizing spreadsheets, documents, and electronic management systems.
